A Study of an Investigational V212/Heat-Treated Varicella-Zoster Virus (VZV) Vaccine in Immunocompromised Adults (V212-002)

Phase 1

Completed

• Conditions: Herpes Zoster-related Complications; Herpes Zoster
• Interventions: Biological: Placebo; Biological: V212

• Registration Number: NCT00535236
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

This study will evaluate the safety and immunogenicity of a heat-treated VZV vaccine in autologous or allogeneic hematopoietic cell transplant (HCT) recipients, human immunodeficiency virus (HIV)-infected participants with a baseline cluster of differentiation 4 (CD4) cell count ≤200 cells/mm\^3, participants with solid tumor malignancy (STM; breast, colorectal, lung, or ovarian malignancies) receiving chemotherapy, and participants with hematologic malignancy (HM; leukemia or leukemia-like disease, lymphoma or lymphoma-like disease, or multiple myeloma). The primary hypothesis is that the heat-treated VZV vaccine will elicit significant VZV-specific immune responses measured by either glycoprotein-based enzyme-linked immunosorbent assay (gpELISA) or VZV gamma interferon enzyme-linked immunospot (IFN-ELISPOT) at 28 days post dose vaccination 4 in, HIV-infected participants, participants with STM, and participants with HM. The primary immunogenicity objective and endpoints were considered by the protocol as exploratory for the autologous and allogeneic HCT groups.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design

Study Timeline

• Study First Submitted: 2007-09-25
• Study First Submitted QC: 2007-09-25
• Study First Posted: 2007-09-26
• Study Start: 2007-11-02
• Primary Completion: 2010-01-25
• Study Completion: 2010-01-26
• Results First Submitted: 2019-01-18
• Results First Submitted QC: 2019-01-18
• Results First Posted: 2019-04-16
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-17
• Last Update Posted: 2019-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 341

Inclusion Criteria

• Men and women > or = to 18 years of age who are scheduled to receive an autologous or allogeneic hematopoietic cell transplant within 60 days of enrollment
• HIV-infected participants with a baseline CD4 cell count < or = to 200 cells/mm^3
• Participants with hematologic malignancies; or participants who are receiving chemotherapy for breast, colorectal, lung, or ovarian malignancies

Read More

Exclusion Criteria

• History of allergy to any vaccine component
• Prior history of HZ
• Prior history of receipt of any varicella or zoster vaccine

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HIV-Placebo	Placebo	Participants receive placebo as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.
Autologous HCT-V212	V212	Participants receive V212 as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.
Allogeneic HCT-Placebo	Placebo	Participants receive placebo as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.
STM-Placebo	Placebo	Participants receive placebo as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.
HM-Placebo	Placebo	Participants receive placebo as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.
STM-V212	V212	Participants receive V212 as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.
Autologous HCT-Placebo	Placebo	Participants receive placebo as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.
Allogeneic HCT-V212	V212	Participants receive V212 as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.
HM-V212	V212	Participants receive V212 as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.
HIV-V212	V212	Participants receive V212 as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.

Primary Outcome Measures

Name	Time	Method
Geometric Mean Fold Rise (GMFR) in Varicella-Zoster (VZV) Antibody Responses Measured by by VZV Interferon-gamma (IFN-g) Enzyme-linked Immunospot (ELISPOT) Assay	Baseline (Day 1 predose vaccination 1) and 28 days postdose 4 (~Day 118)	Blood sample taken at predose (Day 1) and 28 days post vaccination 4 to determine the geometric mean titre (GMT) of VZV antibodies via ELISPOT. The GMFR was calculated as GMT Post-dose/GMT Pre-vaccination
Percentage of Participants Who Experience at Least 1 Serious Adverse Event (SAE)	up to 28 days post vaccination 4 (up to ~Day 118)	An SAE was defined as an adverse event that resulted in death, was life threatening, resulted in persistent or significant disability or incapacity, resulted in or prolonged a hospitalization, is a congenital anomaly or birth defect, is a cancer, was an overdose, or was an important medical event based on appropriate medical judgment. The percentage of participants that experienced at least 1 SAE was summarized.
Geometric Mean Fold Rise (GMFR) in Varicella-Zoster (VZV) Antibody Responses Measured by Glycoprotein Enzyme-linked Immunosorbent Assay (gpELISA)	Baseline (Day 1 predose vaccination 1) and 28 days postdose 4 (~Day 118)	Blood sample taken at predose (Day 1) and 28 days post vaccination 4 to determine the geometric mean titre (GMT) of VZV antibodies via gpELISA. The GMFR was calculated as GMT Post-dose/GMT Pre-vaccination

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With an Injection-site Adverse Event Prompted on the Vaccination Report Card (VRC)	Up to Day 5 post any vaccination	An adverse event (AE) was defined as any untoward medical occurrence in a participant which did not necessarily have a causal relationship with study drug. An AE could therefore have been any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug or a protocol-specified procedure, whether or not considered related to the study drug or protocol-specified procedure. Any worsening of a preexisting condition that was temporally associated with the study drug or protocol-specified procedure was also an AE. The percentage of participants with an injection-site AE prompted on the VRC was summarized.
Percentage of Participants With a Systemic Adverse Event Prompted on the VRC	Up to 28 days post vaccination 4 (up to ~118 days)	An adverse event (AE) was defined as any untoward medical occurrence in a participant which did not necessarily have a causal relationship with study drug. An AE could therefore have been any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug or a protocol-specified procedure, whether or not considered related to the study drug or protocol-specified procedure. Any worsening of a preexisting condition that was temporally associated with the study drug or protocol-specified procedure was also an AE. The percentage of participants with a VRC-prompted systemic (non-injection site) AE was summarized.
Percentage of Participants With Elevated Oral Temperature (≥101.0°F (≥38.3ºC) Prompted on the VRC	Up to 28 days post any vaccination (up to ~118 days)	Participants were instructed on the VRC to take and record their oral (or oral equivalent) temperature daily from the day of vaccination from the date of each vaccine dose through the day prior to the next dose, or for 28 days. Elevated temperature was defined as ≥101.0°F (≥38.3ºC). The percentage of participants that record an elevated temperature was summarized.